Introduction
The vast majority of older adults with Alzheimer’s disease and related dementias (between 60 and 70%) have sleep disturbances, including trouble falling asleep, difficulty staying asleep, poor sleep quality, and insufficient sleep duration or the diagnosis of insomnia disorder.
1 Persons with dementia experience these symptoms due to the degeneration of neural pathways that regulate peoples’ circadian rhythms and affect their physiological and psychological states.
2 Circadian rhythm disorder symptoms include evening agitation, excessive daytime sleepiness, increased sleep latency, and frequent nighttime awakenings.
3,4 The consequences of untreated sleep disturbances in persons with dementia include cognitive dysfunction
5 and accelerated progression of the disease.
6 Untreated sleep disturbances in persons with dementia may also negatively affect caregivers’ sleep, thus increasing caregiver burden,
7 and potentially leading to nursing home placement.
8 Taken together, improving sleep latency, decreasing nighttime awakenings, and improving sleep duration are critical for both older adults with dementia and their caregivers.
Given high fall risk, increased daytime sedation, potential toxicity, and increased risk for cardiac-related mortality associated with pharmacological treatment,
9–11 nonpharmacological approaches for mitigating sleep disturbances are preferred. Nonpharmacological interventions, such as tailored music, that target evening hours between 6
pm and 10
pm, can induce a calm and relaxing state, reducing cortisol levels
12,13 and resulting in fewer sleep disturbances. Specifically, listening to music may have the greatest impact on the time it takes someone to fall asleep (eg, sleep latency) as it promotes relaxation at bedtime. Furthermore, creating a calmer sleep environment by turning on tailored music may improve one’s ability to fall back to sleep after waking in the night. Improving the time it takes one to fall asleep and decreasing night waking may improve overall sleep duration and quality.
Music listening interventions have shown promise in improving sleep quality in primarily healthy older adults.
14–16 Previous studies included music listening interventions and multi-component interventions, where music listening was combined with therapies such as hand massage,
17 active music making,
18 mindfulness awareness practice, tai chi, and art therapy.
19 Prior music listening interventions have consisted of older adults listening to an MP3 or a CD player at bedtime. Music was selected based on sleep-inducing, relaxing characteristics (tempo 60-80 beats per minute without accented beats).
14,15,20–22 However, we found in a systematic review of music interventions and sleep among older adults that only three of 16 studies included older adults with cognitive impairment.
16 In one study, the music selection was based on the preferences of persons with dementia,
23 and in another, the authors selected music based on its familiarity with the person.
24 Findings from these three studies were mixed. Two studies reported improvement in sleep quality,
23,25 and one study reported an increase in nighttime sleep duration in persons with dementia.
24 None used objective measures to examine sleep outcomes. These findings suggest that music interventions may improve sleep outcomes for older adults; however, there remains limited evidence as to the effects of music interventions on a wide range of sleep outcomes in persons with dementia.
Tailored music interventions may be particularly helpful in improving sleep for older adults with dementia for several reasons. First, older adults with dementia continue to have preserved receptive and expressive music abilities as their disease progresses.
26–28 Preserved musical memories in older adults with dementia may be explained by the fact that the brain regions associated with musical memories have delayed atrophy compared to other regions of the brain.
29 Second, music tailored to individual interests and favorite genres can have a personal meaning to older adults with dementia, given that music is often linked to important life events and can be a source of pleasure.
30 Third, musical properties can be easily adapted to personal preferences and sleep-inducing characteristics. For example, one of the fundamental properties of music is beats per minute which can be manipulated to induce a mood or a feeling. Music is universal, is not time intensive, can be tailored, and be a low-cost alternative to other nonpharmacological interventions, such as cognitive-behavioral therapy for insomnia.
Given these benefits, there is a critical need to develop novel tailored music interventions and determine the extent to which music interventions improve sleep disturbances in older adults with dementia. Very few studies examined music interventions aimed at improving sleep disturbances in community-dwelling older adults with dementia using objective and subjective sleep measures. Therefore, the purpose of this wait-list pilot randomized trial was to examine the feasibility of tailored music listening intervention to improve sleep disturbances in community-dwelling older adults with dementia. We hypothesized that persons with dementia who listen to tailored sleep-inducing music at bedtime would experience fewer sleep disturbances if the intervention was feasible and acceptable. The specific aims of this study which can be characterized as Stage 1b along the National Institute on Aging model,
31 were to 1) examine the feasibility of delivering tailored music listening intervention to persons with dementia living at home and their caregivers (dyads); 2) examine the acceptability of the intervention to both the person and the caregiver using a brief survey and qualitative data; and 3) obtain preliminary estimates of treatment efficacy on subjective and objective sleep outcomes.
Discussion
This is the first study to our knowledge to rigorously study a tailored music intervention for its feasibility and acceptability using objective and subjective sleep outcome measures and a control condition. Overall, we would consider our study as mostly feasible as indicated by greater than 85% completion rates of study measures and adherence to wearing the Actigraphs, our primary feasibility outcomes. However, the completion rates of sleep diaries fell below 85%. As a consequence of COVID-19, we were unable to recruit the full intended sample and examine how well participants adhered to the study protocol by listening to music. The results from our secondary feasibility outcomes which included examining rates of recruitment, participant attrition, and reasons for declining to participate in the study were encouraging. Our recruitment rate was low at 26%, while our enrollment and retention rates were high (89.1 and 91%, respectively). The most common reason for those who were screened and were found eligible but did not enroll in our study had to do with ongoing medical problems. Our attrition rate was low at 9%. Our acceptability results were mixed with the average acceptability survey scores falling below the set threshold of 80%. However, analysis of qualitative exit interviews with the dyads revealed to us that the intervention was enjoyable. We found a small effect size on one actigraphically derived sleep outcome (total sleep duration) and one subjective measure of sleep disturbance (PROMIS® Sleep Related Impairment), although the latter was not statistically significant. We learned several lessons from this rigorous pilot study to guide future clinical trials and research to develop efficacious music interventions aimed at improving sleep disturbances in this population.
Findings from our study highlight multiple approaches that are needed to recruit a diverse sample of older adults with dementia and their caregivers. In a 12-month timeframe, we were able to recruit a racially diverse sample of older adults with dementia and their caregivers. Our most successful method of recruitment was from a parent R01 study of a timed behavioral intervention aimed at improving circadian rhythms in older adults with dementia and their caregivers. This points to the importance of partnering with other researchers who are conducting clinical trials in dementia. Persons with dementia and their caregivers may seek multiple opportunities to be involved in research and learn more about their condition and helpful approaches.
59 However, there is a concern about enrolling families who are frequent participants in other trials. It raises the question of generalizability, contamination, and accumulative effects of participating in multiple intervention trials. Participants in multiple clinical trials may be more familiar with the research process and more likely to follow the prescribed research protocol. Given the challenges in recruiting diverse persons with dementia in clinical research, our recruitment efforts resulted in a relatively low (26%) initial screening rate. The most common reason for not being able to screen participants had to do with us not being able to reach them. Once we screened the dyads, 89.1% agreed to participate in the study. Our enrollment rate was comparable to another study run with older adults in the same period.
60 Similar to our study findings, prior research indicates that recruitment of individuals with dementia and their caregivers requires a multi-pronged approach, community and clinician partnerships, as well as flexibility with scheduling.
59,61,62
When examining the intervention acceptability survey, we found mixed results. While it may seem that music interventions are easy to carry out, we should anticipate potential challenges and monitor adherence in older adults with dementia and caregivers. Only a third of the dyads felt that the study benefited persons with dementia. This relatively low rate of perceived benefit may be attributed to caregivers not seeing the immediate benefits of listening to music in older adults with dementia and correspond to actigraphically derived sleep outcomes (sleep latency and WASO) not improving after the intervention. The caregiver burden associated with study participation and filling out the questionnaires may have overshadowed any of the perceived positive benefits for persons with dementia. We heard about the difficulties of filling out paperwork from three participants in our qualitative interviews. Additionally, some caregivers did not sleep in the same room or bed as the person with dementia or worked night shifts and were away from the home making them less likely to know how the person with dementia slept during the night. Furthermore, since the intervention was targeted at persons with dementia and not the caregivers, future interventions targeting the caregiver and the dyad as a unit may decrease caregiver burden as well as their sleep disturbances and thus improve their perception of benefits for persons with dementia. Even though persons with dementia reported that they enjoyed listening to music, their caregivers did not perceive the music intervention to be beneficial. The dyads were satisfied with the study procedures and the majority would recommend the study to others. Our qualitative data provided additional insight into our quantitative findings. In exit interviews, participants shared with us that listening to music was relaxing, and enjoyable, helped persons with dementia sleep and brought back memories despite most caregivers reporting no tangible benefits in the acceptability survey.
When we examined initial effect sizes across objective and subjective sleep outcomes, we found small to moderate effects with two objective sleep outcomes (sleep latency and WASO) in favor of the control group and one objective sleep outcome (total sleep duration) in favor of the intervention group. This suggests that all participants fell asleep faster and were awake less after falling asleep after the study. One possible explanation is that completing sleep diaries may have brought more awareness of poor sleep habits to caregivers. Although practicing good sleep hygiene is beneficial, there is limited evidence to suggest that sleep hygiene alone is enough to improve sleep disturbances.
63 More research is needed to determine how caregivers’ increased insight into person’s with dementia sleep habits affects sleep outcomes. Subjective ratings of sleep impairment improved in the intervention group but remained relatively constant in the wait-list control group. One other explanation is that our intervention was not successful at improving the time it takes a person to fall asleep faster and stay asleep, but did have a positive effect of increasing total sleep duration. Our study findings add to the body of knowledge examining the impact of music on sleep in nursing home residents,
23 older adults with subjective memory loss
25 and probable Alzheimer’s disease.
24 Tailored music is an innovative and widely available approach that can be used to target sleep disturbances among older adults with dementia. This study focused on community-dwelling older adults with dementia and their caregivers combining the sleep-inducing properties of music with its ability to be tailored to an individual. Given that we found mixed preliminary efficacy results with small effect sizes in favor of the control group, our music intervention warrants further development, refinement, and testing.
We acknowledge several study limitations. First, we were unable to recruit the targeted sample size due to institutional restrictions placed on in-person research due to the COVID-19 pandemic and the limited resources available to adapt the intervention delivery. As recently highlighted in a protocol paper of a large Phase III efficacy of the WeCareAdvisor intervention targeted at caregivers for individuals with dementia, major modifications to the design were needed to adapt to the COVID-19 pandemic.
64 Given that our study was a small-scale feasibility study we could not justify major modifications; thus, we stopped recruitment in the Summer of 2020. Second, the sample recruited for this study came primarily from a larger nonpharmacological clinical trial. Third, this feasibility study was not powered to formally test the intervention efficacy which limits the generalizability of our study findings. Fourth, we were unable to access the fidelity of the intervention because of a technical error in downloading usage data from smart tablets and due to a change in information technology staff overseeing the data download. Fifth, both participants and outcome assessors were not masked to group assignment which may have biased their responses. Lastly, many participants in our study did not have a formal diagnosis of dementia. Individuals with a formal diagnosis of dementia may behave differently from those with self-reported memory impairment.
Despite the limitations, our study also has important strengths. We recruited a diverse sample of older adults with dementia and their caregivers with regard to their reported race and education. Over 80% of our sample identified themselves as Black or African American. Forty-two percent of persons with dementia and caregivers completed high school or less. In addition, we used a combination of subjective and objective sleep measures to examine sleep disturbances in persons with dementia. Furthermore, we used a novel approach for selecting tailored music that not only accounted for personal genre preference but sleep-inducing music qualities as well.
We learned several lessons from this study that can inform future research focused on music-based interventions for persons with dementia targeting sleep disturbances. It is essential that future studies that are focused on developing interventions for older adults with dementia and their caregivers involve stakeholders from the beginning. User-centered design, for example, is one method that includes the end users in the initial design phases of the research project. Future clinical trials that include music-based interventions may benefit from including an attention control condition such as sleep education. This might also help with recruitment, as McPhillips and colleagues
59 found that one reason dyads, which include a person living with dementia, enroll in a clinical trial is because they want to learn information and gain knowledge. Given the universality of music and the fact that caregivers often provide care for persons with dementia, research teams could address dyadic health and the impact of music on caregivers’ well-being. For example, the Theory of Dyadic Illness Management may guide researchers to measure dyadic health and how music can be helpful for both members of the dyad.
65 In addition, our mixed acceptability findings can aid in identifying novel strategies to improve future study design, such as limiting the amount of study-associated paperwork and introducing passive ways to collect outcomes of interest. Finally, echoing the call for mechanistic clinical trials from the National Institutes of Health Sound Health initiative, examining the mechanism of music-based interventions for sleep will provide the knowledge of putative targets and optimize the development of future music-based interventions. Potential mechanisms of how music can promote sleep include thought redirection (focusing on the music rather than intrusive or negative thoughts), promoting relaxation,
66 and neural entrainment which refers to a process of synchronization between musical rhythm and internal bodily rhythm.
67
In summary, the results of this feasibility RCT were mixed. While we did not meet our acceptability targets, the results of our qualitative findings provided additional insight into our quantitative findings. The initial effect size calculations provide support for further refinement and testing of the intervention. Based on our findings, future research should involve stakeholders in the initial phases of intervention development, integrate other components of sleep hygiene, and examine mechanisms of action. Our study findings may inform future design and formal efficacy testing of tailored music-based interventions for persons with dementia and their caregivers including those that aim to reduce caregiver burden and sleep disturbances.